BEUDAMED
    FDA Enforcement Class II Ongoing

    ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System

    Recall: Z-1857-2025 · Reported June 4, 2025

    Enforcement

    Recall Number
    Z-1857-2025
    Event ID
    96780
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Onkos Surgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 4, 2025
    Initiation Date
    September 22, 2024
    Classification Date
    May 28, 2025
    Address
    77 E Halsey Rd, N/A, Parsippany, NJ, 07054-3714, United States

    Description

    ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System

    Reason

    Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur.

    Code Info

    Part Number: 25001040E. UDI-DI B27825001040E0. Lot Numbers: 1989873, 1989874

    Distribution

    US Nationwide distribution in the states of AZ, CA, FL, FL, MD, MO, NC, TN.

    Quantity

    24 units